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Bear Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K992788BEAR CUB 750 PSVSeptember 16, 1999
K983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBENovember 20, 1998
K912619BEAR 7 VENTILATORJune 11, 1992
K900637BEAR CEM CONTROLLERAugust 3, 1990
K896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLYJanuary 22, 1990
K893034VHS 820 HUMIDIFIER, MODIFICATIONJuly 14, 1989
K890724MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITORMarch 30, 1989
K882764BEAR EVC-100 CONTROLLERSeptember 30, 1988
K881335BEAR 3 VENTILATORAugust 4, 1988
K872660BEAR NVM-1February 12, 1988
K873634BEAR VH-820 HUMIDIFIERDecember 2, 1987
K871985BEAR JET VENTILATOR FOR USE DURING (ESWL)June 15, 1987
K864589TRI-SERVICE OMV VAPORIZERJune 5, 1987
K864590AM1000May 4, 1987
K864605VAPLOKFebruary 3, 1987
K864588PENLON CIRCLE SYSTEMFebruary 3, 1987
K860692PTR MK II VENTILATORMay 21, 1986
K853346BEAR NICU-1September 11, 1985
K850795AIR COMPRESSORMay 28, 1985
K842688BEAR JET-150 VENTILATORJuly 26, 1984